Adult Dosing

• Not applicable for use in adults

Pediatric Dosing

Respiratory distress syndrome

• Recommended dose: 5.8 mL/kg birth weight intratracheally; administer up to 4 doses in the first 48 hrs of life
• Max dose: 5.8 mL/kg birth weight, not to exceed more than 4 doses or dosing frequency more than every 6 hrs

• Administered intratracheally by instillation using a 5-French end-hole catheter
• Warm the product before use; discard the product if not used within 2 hrs of warming
• Refer to the package insert for directions for use and dosing chart

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Intended for intratracheal use only
• Exogenous surfactants can rapidly affect oxygenation and lung compliance
• Therapy should be administered only by clinicians well trained and experienced in the resuscitation, intubation, stabilization, and ventilatory management of premature infants in a hospital setting, fully facilitated to care for critically ill neonates
• Infants receiving therapy should be assessed frequently, both clinically and through investigations, for any changes in respiratory status so that the oxygen and ventilatory support can be modified to respond to these changes
• Discontinue treatment and initiate appropriate measures on development of bradycardia, hypotension, reflux of drug into the endotracheal tube (ETT), ETT blockage, and oxygen desaturation. Consider suctioning of the ETT or reintubation if airway obstruction persists or is severe. Once the patient is stabilized, dosing may proceed with appropriate monitoring
• Instances of death, multi-organ failure, sepsis, anoxic encephalopathy, renal failure, hypoxia, pneumothorax, hypotension, and pulmonary embolism are more in ARDS patients receiving lucinactant compared to those receiving standard care. Not indicated in the treatment of ARDS

Pregnancy Category: Not Applicable

Breastfeeding: Not Applicable

• RESP: ETT reflux, dose interruption, ETT obstruction, apnea, intraventricular hemorrhage, pulmonary air leaks, pulmonary interstitial emphysema, pulmonary hemorrhage, pneumothorax, hypoxia/decreased oxygen saturation
• CV: Bradycardia, patent ductus arteriosus, intraventricular hemorrhage, periventricular leukomalacia, hypotension, pulmonary embolism
• CNS: Anoxic encephalopathy
• EENT: Retinopathy of prematurity
• GU: Renal failure
• GI: Necrotizing enterocolitis
• MISC: Sepsis, death, multi-organ failure, pallor

• Pulmonary surfactant; reduces surface tension at the air-liquid interface of the alveolar surfaces during ventilation and stabilizes the alveoli against collapse at resting transpulmonary pressures
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Surfaxin

US Availability

Surfaxin

• SUSP: 8.5 mL/vial

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Pulmonary

anti-rds Agents

Lung Surfactants